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PERFORMANCE ASSURANCE GUIDE - A guide for developing and implementing a medical device performance assurance program - Essential process information for Clinical Engineering (1st edition)
CAN/CSA-C22.2 NO. 60601-1:14 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Adopted IEC 60601-1:2005, third edition, 2005-12, including amendment 1:2012, with Canadian deviations) | Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles (norme CEI 60601-1:2005 adoptée, troisième édition, 2005-12, y compris l'amendment 1:2012, avec exigences propres au Canada)
CAN/CSA-ISO 14971-07 (R2017) - Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)
Z8000-11 (R2016) - Canadian health care facilities
Z8002-14 - Operation and maintenance of health care facilities
A Performance Assurance (PA) program is a medical device risk management system - critical to the clinical engineering function - that clearly defines performance verification, preventive maintenance and operational safety testing. A variety of professionals are involved in managing a clinical engineering department including: Medical equipment management; biomedical equipment management; biomedical engineering; clinical engineering; clinical equipment management; healthcare technology management; and maintenance & operations personnel. An effective PA program provides several benefits such as improved patient safety, reduced corporate risk, and increased organizational efficiency and effectiveness.
This Guide provides a framework for the development and implementation of a comprehensive and effective regional PA program. This publication is not a standard and any reference to published standards is presented merely as reference for additional information sources to consult where necessary.